UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059185 |
|---|---|
| Receipt number | R000067697 |
| Scientific Title | The Effectiveness of Introducing an AI Meal Logging App "FoodLogAthl" to Improve Dietitian Efficiency and Reduce Patient Documentation Burden: A Practical Study |
| Date of disclosure of the study information | 2025/09/29 |
| Last modified on | 2026/01/27 13:56:17 |
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Basic information
Public title
A Study on the Effects of Introducing the AI Meal Logging App "FoodLogAthl" to Improve Dietitian Efficiency and Reduce Patient Burden
Acronym
AI Meal Logging App Study
Scientific Title
The Effectiveness of Introducing an AI Meal Logging App "FoodLogAthl" to Improve Dietitian Efficiency and Reduce Patient Documentation Burden: A Practical Study
Scientific Title:Acronym
FoodLogAthl Effectiveness Study (FLES)
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus, Hypertension, Dyslipidemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to verify in a clinical setting whether the use of an AI meal logging app can reduce both the workload of dietitians and the documentation burden of patients in the practice of optimal nutritional assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Workflow efficiency of dietitians' nutritional assessment tasks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study is an intervention study using a single-arm A-B design (baseline phase-intervention phase) conducted at a single facility.
Intervention:Use of the AI-based dietary recording application FoodLogAthl.
Study Period:The baseline phase (Phase A) lasts for one month, followed by the intervention phase (Phase B) lasting for two months. During this period, participants record their dietary intake for five consecutive days prior to each monthly nutrition counseling session, resulting in a total of 15 recording days.
Intervention Dose:The intervention consists solely of the use of the application. Participants are instructed to take and upload one photograph per meal for all meals consumed, including snacks.
Frequency:Dietary recording is conducted for five days per month over three consecutive months. Detailed nutritional assessment by a registered dietitian is performed once per month after each face-to-face nutrition counseling session.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults aged 20~75 years attending Zushi Orthopedic and Internal Medicine Clinic who have been diagnosed with type 2 diabetes, hypertension, dyslipidemia, or any combination of these conditions.
Determined by the attending physician to be eligible for nutritional counseling by a registered dietitian.
Able to perform basic operations on their own smartphone (iOS 14.0 or later/Android 6.0 or later) and agree to install the study application.
Key exclusion criteria
Individuals with severe renal impairment (eGFR 30 mL/min/1.73m2) or eating disorders, or those judged by the principal investigator or attending physician to be unsuitable for the dietary recording method used in this study.Individuals with cognitive decline or other conditions making it difficult to understand the study or operate the application independently (HDS-R score 20, or as determined by the attending physician).Individuals from whom informed consent cannot be obtained.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Noa |
| Middle name | |
| Last name | Ouchi |
Organization
Graduate School, Kanagawa University of Human Services
Division name
Graduate School of Health and Social Welfare
Zip code
238-8522
Address
1-10-1 Heisei-cho, Yokosuka-shi, Kanagawa, Japan
TEL
0468282650
62512002.ypm@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Sunto |
Organization
Graduate School, Kanagawa University of Human Services
Division name
Graduate School of Health and Social Welfare
Zip code
238-8522
Address
1-10-1 Heisei-cho, Yokosuka-shi, Kanagawa, Japan
TEL
0468282650
Homepage URL
suntou-a@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa University of Human Services
Address
1-10-1 Heisei-cho, Yokosuka-shi, Kanagawa, Japan
Tel
0468282650
suntou-a@kuhs.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067697
